General Medication Labeling

The issue of any promotional material that is not in accord with the MA, is inconsistent with labelling approved by the regulatory authority and is misleading is a criminal offence imder the Medicines Act (1968) and carries financial penalties and potential for a custodial sentence. Conviction of such an offence usually leads to erasure from the Medical Register by the General Medical Council (GMC). 

Solicitations for release of new medications are generally very extensive, sometimes thousands of pages. The information has to be enough to justify the affirmations contained in the label of the proposed medication with respect to effectiveness, dosage, and safety. The exact composition of the content on the medication label is usually decided by consensus between the proponent and the FDA. 

Confusion can arise when a medication is generally deemed useful by the medical profession in a condition for which its use has not been FDA approved. Marketed drugs are frequently found helpful for disorders beyond the formal labeled indications. Part of the reason for this situation is the long and expensive process needed to produce sufficient data to obtain FDA labeling approval, which are estimated to cost as much as 300,000,000 to 1 billion. Frequently, there is not sufficient monetary incentive to warrant such expenditure, yet a compound is often found to be effective by researchers and clinicians in a given medical discipline. 

This approach is generally used when there has been at least some antidepressant response ( 355). It generally refers to the addition of a medication that is not formally labeled as an antidepressant, which is in contrast to the combined use of two antidepressants, as discussed later in this section. 

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